Clinical Operations

Clinical operations is critical for clinical trial management and works as a guardian for ensuring the reliability of clinical data and subject protection. Symyoo’s Clinical operations team offers solid know-how and experience of study-specific project management, monitoring, and scientific and medical communication for all stages of clinical trials in diverse therapeutic areas.


Symyoo’s clinical research associates (CRAs) are highly knowledgeable of good clinical practice and local regulations and are committed to excellence in every study, ensuring the integrity of the study, adherence to protocol, quality of measurements, safety of subjects and valid data.

 

Clinical Project Management Services

• Trial Planning and Milestone Management
• Country Feasibility Assessment
• Site Qualification Analysis and Site Selection
• Clinical Trial Agreement Negotiation
• IRB/EC Approval
• Regulatory Document Management
• Investigational Product Supply Management
• Site Management and Performance Monitoring
• Site Training and Scientific Communication

Clinical Monitoring Services

• Study Monitoring Plan Documentation
• Site Monitoring Visits: Site Initiation Visit, Interim Visits and Site Close-out Visit
• Regulatory Compliance Monitoring
• Investigational Product Monitoring
• Medical Safety Monitoring